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Continuous glucose monitoring cohort (intervention) for Type 2 Diabetes

N/A
Recruiting
Led By Kevin Cowart, PharmD, MPH
Research Sponsored by University of South Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to end of study (12 weeks)
Awards & highlights

Summary

This is a pilot study. The goal of this prospective cohort study is to determine impact of pharmacist-led continuous glucose monitoring on glycemic control and health behavior change in people with type 2 diabetes. The main questions it aims to answer are: 1. to assess change in hemoglobin A1c in people with type 2 diabetes using continuous glucose monitoring under a pharmacist-led approach as compared to a pharmacist-led approach utilizing no continuous glucose monitoring (only self-monitoring blood glucose with a glucometer). 2. to assess change in continuous glucose monitoring-derived glycemic outcomes among the pharmacist-led continuous glucose monitoring cohort (intervention group) 3. to assess change in health behavior among the pharmacist-led continuous glucose monitoring cohort (intervention group)

Eligible Conditions
  • Type 2 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to end of study (12 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to end of study (12 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in hemoglobin A1c
Secondary study objectives
>70% Time in Range
Continuous Glucose Monitoring Survey Responses
Glycemic Variability
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Self-monitoring of blood glucose cohort (historical cohort)Experimental Treatment0 Interventions
A retrospective chart review will be performed on patients seen by a clinic pharmacist between 1/1/2020-7/1/2024. Subjects in this group will include adults ≥18 years of age with type 2 diabetes and a hemoglobin A1c ≥ 8% and using a glucometer to monitor blood sugar. Exclusion criteria will be use of any continuous glucose monitoring device within the prior 6 months of the index date (defined as first visit with a pharmacist during study time frame).
Group II: Continuous glucose monitoring cohort (intervention)Experimental Treatment1 Intervention
Freestyle libre 2 sensor devices will be used to monitor glucose. The sensors are worn on the upper arm and changed every 14 days. Each subject will have 5 visits with a pharmacist over 12 weeks. Subjects meeting inclusion criteria will include adults ≥18 years of age with type 2 diabetes and a hemoglobin A1c ≥ 8%. Subjects must have a compatible smartphone with the freestyle libre 2 sensor system. Subjects must have access to a glucometer to check blood glucose. Subjects must not have worn a continuous glucose monitor in the last 6 months to be eligible.

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Who is running the clinical trial?

University of South FloridaLead Sponsor
422 Previous Clinical Trials
189,207 Total Patients Enrolled
Kevin Cowart, PharmD, MPHPrincipal InvestigatorUniversity of South Florida
~13 spots leftby Aug 2025
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